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2026 data FDA MAUDE openFDA

Suture, Absorbable, Synthetic, Polyglycolic Acid

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Suture MID-BOOK · MAUDE

#63 of 1000 · 52,543 reports · 1994–2026

  • BOOK 52,543 reports
  • RANK #63 of 1000
  • DEATH 86 death-typed
  • INJ 12,565 injury-typed
  • MALF 39,734 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 9,119
  • PHOTO Generator

Nearest event-volume peer: Generator, Oxygen, Portable (62 report gap)

Suture, Absorbable, Synthetic, Polyglycolic Acid sits #63 of 1000 among tracked device types with 52,543 MAUDE reports spanning 1994–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 23.9% corpus 30.4% · below corpus mean (-6.5 pp)
  • MALF 75.6% corpus 64.5% · above corpus mean (+11.1 pp)

Lead product-problem code Break is 36% of coded problems · Lead manufacturer ETHICON INC. accounts for 63% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Suture in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Suture, Absorbable, Synthetic, Polyglycolic Acid carries 52,543 MAUDE reports, ranked #63 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 39,734 (75.6%)
Injury 12,565 (23.9%)
Other 88 (0.2%)
Death 86 (0.2%)
70 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

38,241 (71.4%)
Required Intervention 9,565 (17.9%)
Other 3,967 (7.4%)
R 719 (1.3%)
Hospitalization 499 (0.9%)
O 243 (0.5%)
H 109 (0.2%)
Death 71 (0.1%)
Life Threatening 31 (0.1%)
L 26 (0.0%)
S 25 (0.0%)
Disability 25 (0.0%)
D 17 (0.0%)
Congenital Anomaly 10 (0.0%)
Invalid Data 2 (0.0%)
C 1 (0.0%)

Top Product Problems

Break 16,749
Material Separation 9,733
Detachment of Device or Device Component 7,931
Adverse Event Without Identified Device or Use Problem 4,969
Appropriate Term/Code Not Available 1,004
Material Integrity Problem 861
Material Frayed 604
Patient-Device Incompatibility 555
Unraveled Material 475
Insufficient Information 347
Detachment Of Device Component 346
Material Split, Cut or Torn 346
Device Markings/Labelling Problem 319
Manufacturing, Packaging or Shipping Problem 317
Component Missing 285
Product Quality Problem 258
Failure To Adhere Or Bond 248
Material Twisted/Bent 245
Defective Component 210
Device Contaminated During Manufacture or Shipping 196

Yearly Trend

94
1994: 17
95
1995: 25
96
1996: 99
97
1997: 417
98
1998: 155
99
1999: 159
00
2000: 174
01
2001: 379
02
2002: 221
03
2003: 145
04
2004: 178
05
2005: 156
06
2006: 172
07
2007: 274
08
2008: 194
09
2009: 287
10
2010: 587
11
2011: 637
12
2012: 868
13
2013: 898
14
2014: 1,410
15
2015: 935
16
2016: 1,112
17
2017: 1,499
18
2018: 2,229
19
2019: 3,564
20
2020: 3,415
21
2021: 4,506
22
2022: 4,814
23
2023: 5,070
24
2024: 7,226
25
2025: 9,119
26
2026: 1,602

Related Entities for Suture, Absorbable, Synthetic, Polyglycolic Acid

Top Manufacturers

ETHICON INC. 27,769
DAVIS & GECK CARIBE LTD 5,849
COVIDIEN LP LLC NORTH HAVEN 5,644
ETHICON, INC. 2,919
COVIDIEN SURGICAL 1,558

Event Locations

31,999 (60.9%)
I 15,168 (28.9%)
HOSPITAL 3,207 (6.1%)
OTHER 1,084 (2.1%)
UNKNOWN 667 (1.3%)
NO INFORMATION 233 (0.4%)
INVALID DATA 70 (0.1%)
HOME 69 (0.1%)
OUTPATIENT TREATMENT FACILITY 20 (0.0%)
AMBULATORY SURGICAL FACILITY 13 (0.0%)
AMBULATORY SURGICAL CENTER 7 (0.0%)
OPERATING ROOM 3 (0.0%)
HOSPICE 2 (0.0%)
NURSING HOME 1 (0.0%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Suture, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (52,543 here).

Generator, Oxygen, Portable 52,481 Endoscopic Video Imaging System/Component 53,347 Stimulator 51,502 Stimulator 51,263

Similar death-typed counts

Nearest other device types by death-typed report count (86 here), distinct from the volume row.

Surgical Device 86 Thoracolumbosacral Pedicle Screw System 86 Continuous, Ventilator, Home Use 85 Pulse-Generator, Pacemaker, External 85

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Suture are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Suture; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.